$MDT (Medtronic plc)

$MDT Medtronic plc, today announced first-of-its-kind findings from two independent studies that have identified a gene associated with life-threatening abnormal heart rhythms. The study results were presented in a hotline session at the 2015 European Society of Cardiology Congress in London.

$MDT announced FDA approval and U.S. launch of the Intellis platform for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems, such as battery performance, and can power the Evolve workflow.

$MDT voluntarily recalls specific lots of infusion sets used with all models of Medtronic insulin pumps due to a certain discontinued component. The recall comes after reports from patients that a component, the vent membrane, may be susceptible to being blocked by fluid during priming and fill-tubing, which can lead to over-delivery of insulin.

$MDT's IN.PACT Admiral Drug-Coated Balloon received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of peripheral artery disease in the upper leg. Before $MDT can begin commercialization, it must partner with Japanese MHLW to gain reimbursement to ensure broader access to this therapy.

$MDT launched a long-term clinical study of its INFUSE Bone Graft for use during Posterolateral Fusion (PLF) and Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures. The first patient has been enrolled in the PLF study. The 10-year program is looking to enroll 550-700 individuals between the pilot and pivotal studies of both procedures.

On the IT disruption, $MDT said it is very difficult to separate and quantify the impact related to the outage. The company did say that the outage is not material to 1Q18 revenue or EPS, but stated that it is "very difficult to quantify beyond that."

$MDT said it is not really focused on transformative M&A, but will continue to have a disciplined approach to pursuing tuck-in acquisitions. Notably, the company is still in the last year of integration of Covidien.

$MDT's overall sensor unit demand has more than doubled in the past 10 quarters since launching the MiniMed 640G. The company now expects to see increasing revenue momentum from several new product launches over the balance of the fiscal year 2018.

On June, $MDT experienced an IT system disruption, impacting customer ordering, distribution, and manufacturing processes globally. The company said that the IT disruption did have some impact on the overall performance for 1Q18, but it was not material to revenue or earnings.

$MDT posted a 9.4% YoY increase in profit to $1.02Bil, or $0.74 per share, for 1Q18, as the medical device maker saw a strong demand for its heart and vascular devices. The Dublin-based company generated most of its sales from heart devices, spinal implants and insulin pumps, resulting in a 3.1% growth in revenue to $7.4Bil.

$CAH closed purchase of $MDT's Patient Care, Deep Vein Thrombosis and Nutritional Insufficiency business for $6.1Bil. The acquisition was funded with a combination of $4.5Bil in new senior unsecured notes, existing cash and borrowings under $CAH's existing credit arrangements.

$MDT completes the sale of its Patient Care, Deep Vein Thrombosis (Compression), and Nutritional Insufficiency businesses within the Patient Monitoring & Recovery division to $CAH for $6.1Bil in cash. The company expects modest dilution on a net basis to its FY18 non-GAAP EPS of approx. $0.18.

$LIVN appointed Keyna Skeffington as SVP and General Counsel. Skeffington most recently served as Vice President of Legal – Corporate and Securities, Deputy General Counsel and Assistant Secretary at $MDT.

$MDT announced the expanded FDA approval of the self-expanding CoreValve Evolut transcatheter aortic valve replacement platform to include patients with symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery.

$MDT said data from a recent study showed that its
cardiac resynchronization therapy devices reduced healthcare system costs and
improved therapy delivery in heart failure patients. A
European health-economic analysis indicated that Medtronic’s AdaptivCRT extended
life expectancy of patients by about four months, while lowering healthcare
costs.

$MDT said its Reactive ATP therapy slows the progression of atrial fibrillation (AF) in patients with implanted cardiac devices. A robust, real-world analysis of nearly 8,800 patients was presented as a late breaking clinical trial at EHRA Europace-Cardiostim 2017.

$MDT expects FY18 to have
operating margin improvement, with greater strength in 2H18. GM on a constant
currency basis is expected to be flat to slightly improve throughout FY18, with
modest pricing pressure offset by operating improvement. $MDT also expects
currency to negatively affect GM in 1H18, with a greater impact in 1Q18 than in
2Q18.